A clincal trial to study the effects of Bosutinib (SKI-606) compared with Imatinib in patients newly diagnosed with philadelphia chromosome positive chronic myelogenous leukemia (CML).
Phase 3
Completed
- Conditions
- Health Condition 1: null- Chronic Myelogenous Leukemia
- Registration Number
- CTRI/2009/091/000491
- Lead Sponsor
- Wyeth Research Wyeth Pharmaceuticals India Private Limited A Subsidiary of Pfizer Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 509
Inclusion Criteria
1. Cytogenetic diagnosis of chronic phase Ph+ CML diagnosed less than 6 months.
2.Diagnosis of CML chronic phase confirmed.
3.Adequate hepatic and renal function.
4.Able to take oral tablets.
5.Age greater than or equal to 18 years.
Please note: there is no upper age limit for inclusion criteria for this trial
Exclusion Criteria
1. Exclusions include Philadelphia negative CML.
2.Prior anti-leukemia treatment.
3.Prior stem cell transplant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cytogenetics response rateTimepoint: One year
- Secondary Outcome Measures
Name Time Method Major molecular response rate, duration of complete cytogenetics response, complete hematologic response, and major molecular response, time to transformation to accelerated and blast phases, population PK, comparative safetyTimepoint: One year